Serum Institute of India (SII) in Pune on Sunday applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford-AstraZeneca Covid-19 vaccine in the country. SII cited "unmet medical needs due to the pandemic" and "interest of the public at large," as the reasons for seeking emergency use authorisation, official sources said.

This comes a day after Pfizer India became the first to seek a similar approval from India's drug regulator for its own Covid-19 vaccine in the country, after its parent company got clearance in the UK and Bahrain for mass use.

The phase-three clinical trial of the Oxford Covid-19 vaccine, Covishield, is being conducted by the SII, co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.

ICMR had said last month that it, along with SII, based on phase two and three clinical trial results, will pursue early availability of the vaccine for India.

According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.

Official sources, citing the SII application, said the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 infections, news agency PTI said in its report.

The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial Covid-19 mortality and morbidity, the firm is learnt to have said.

"In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae.

"Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," a source told PTI, quoting the application.